S. Baertschi

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Pharmaceutical Stress Testing : Predicting Drug Degradation

Steven W. Baertschi, S. Baertschi, 2005 .

Impurity investigations by phases of drug and product development

A. Sreedhara, S. Baertschi, B. Olsen, 2017 .

Role of ‘‘mass balance’’ in pharmaceutical stress testing

S. Baertschi, M. Nussbaum, A. Kaerner, 2005 .

Determination of relative UV response factors for HPLC by use of a chemiluminescent nitrogen-specific detector.

S. Baertschi, M. Nussbaum, P. Jansen, 2002, Journal of pharmaceutical and biomedical analysis.

Assessing mass balance in pharmaceutical drug products: New insights into an old topic

S. Baertschi, B. Pack, M. Nussbaum, 2013 .

Strategies for investigation and control of process- and degradation-related impurities

S. Baertschi, B. Olsen, 2004 .

On-column nitrosation of amines observed in liquid chromatography impurity separations employing ammonium hydroxide and acetonitrile as mobile phase.

T. Harris, C. Hadden, S. Baertschi, 2013, Journal of chromatography. A.

Formation of thiol conjugates of 9-deoxy-delta 9,delta 12(E)-prostaglandin D2 and delta 12(E)-prostaglandin D2.

L. Roberts, T. Harris, S. Baertschi, 1990, Biochemistry.

Formation of epoxyalcohols by a purified allene oxide synthase. Implications for the mechanism of allene oxide synthesis.

A. Brash, T. Harris, S. Baertschi, 1993, The Journal of biological chemistry.

Degradation and Impurity Analysis for Pharmaceutical Drug Candidates

Karen M. Alsante, T. Sharp, S. Baertschi, 2011 .

Stress Testing: The Chemistry of Drug Degradation

Karen M. Alsante, S. Baertschi, Dinos Santafi anos, 2016 .

Artifacts Generated During Azoalkane Peroxy Radical Oxidative Stress Testing of Pharmaceuticals Containing Primary and Secondary Amines.

P. Harmon, S. Baertschi, Todd Zelesky, 2015, Journal of pharmaceutical sciences.

Strategies To Address Mutagenic Impurities Derived from Degradation in Drug Substances and Drug Products

Steven W. Baertschi, Andrew Teasdale, Mark H. Kleinman, 2015 .

A stress testing benchmarking study

Karen M. Alsante, S. Baertschi, Linda Martin, 2003 .

Formation of a cyclopropyl eicosanoid via an allene oxide in the coral Plexaura homomalla: implications for the biosynthesis of 5,6-trans-prostaglandin A2

A. Brash, T. Harris, S. Baertschi, 1989 .

Isolation and characterization of natural allene oxides: unstable intermediates in the metabolism of lipid hydroperoxides.

A. Brash, T. Harris, S. Baertschi, 1988, Proceedings of the National Academy of Sciences of the United States of America.

Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 2: Topical Drug Product.

Steven W Baertschi, Robert A Reed, Mark H Kleinman, 2015, Journal of pharmaceutical sciences.

Absolute configuration of cis-12-oxophytodienoic acid of flaxseed: implications for the mechanism of biosynthesis from the 13(S)-hydroperoxide of linolenic acid.

A. Brash, T. Harris, S. Baertschi, 1988, Biochemistry.

Maillard reaction of lactose and fluoxetine hydrochloride, a secondary amine.

R. Johnson, M. Miller, M S Miller, 1998, Journal of pharmaceutical sciences.

Implications of in-use photostability: proposed guidance for photostability testing and labeling to support the administration of photosensitive pharmaceutical products, part 1: drug products administered by injection.

Steven W Baertschi, Robert A Reed, D. Clapham, 2013, Journal of pharmaceutical sciences.

Investigation of the mechanism of racemization of litronesib in aqueous solution: unexpected base-catalyzed inversion of a fully substituted carbon chiral center.

Michael A. Watkins, G. Stephenson, T. Harris, 2014, Journal of pharmaceutical sciences.

A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision.

Karen M. Alsante, Steven W. Baertschi, H. Tønnesen, 2010, Journal of pharmaceutical sciences.

The role of analytical chemistry in drug-stability studies

S. Baertschi, S. Görög, 2013 .

Stress testing: Analytical considerations

S. Baertschi, P. Jansen, W. K. Smith, 2016 .

Isolation and structure elucidation of the major degradation products of cefaclor formed under aqueous acidic conditions.

M. W. Collins, G. Stephenson, S. Baertschi, 1997, Journal of pharmaceutical sciences.

Isolation and structure elucidation of a novel product of the acidic degradation of cefaclor.

M. W. Collins, S. Baertschi, L. A. Spangle, 1993, Journal of pharmaceutical sciences.

Analytical methodologies for discovering and profiling degradation-related impurities

S. Baertschi, 2006 .

Assessing the Relevance of Solution Phase Stress Testing of Solid Dosage Form Drug Products: A Cross-Industry Benchmarking Study.

S. Baertschi, L. Allain, Chloe Q. Wang, 2021, Journal of pharmaceutical sciences.

On non-cyclooxygenase prostaglandin synthesis in the sea whip coral, Plexaura homomalla: an 8(R)-lipoxygenase pathway leads to formation of an alpha-ketol and a Racemic prostanoid.

A. Brash, T. Harris, S. Baertschi, 1987, The Journal of biological chemistry.

Non-Cyclooxygenase Prostaglandin Biosynthesis: Formation of PGA 3 Isomers Via an Allene Oxide

A. Brash, T. Harris, S. Baertschi, 1990 .

Formation of prostaglandin A analogues via an allene oxide.

A. Brash, T. Harris, S. Baertschi, 1990, The Journal of biological chemistry.

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 2: Safety Considerations of Impurities in Pharmaceutical Products and Surveying the Impurity Landscape

Karen M. Alsante, G. Stephenson, R. Reed, 2013, AAPS PharmSciTech.

Preparation of the 8,9-epoxide of the mycotoxin aflatoxin B1: the ultimate carcinogenic species

K. Raney, T. Harris, M. Stone, 1988 .

Allene oxides as intermediates in biosynthesis of ketols and cyclopentenones.

A. Brash, T. Harris, S. Baertschi, 1989, Advances in prostaglandin, thromboxane, and leukotriene research.

Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms

Karen M. Alsante, Andreas M. Abend, Margaret S. Landis, 2013, AAPS PharmSciTech.

Characterization of impurities formed by interaction of duloxetine HCl with enteric polymers hydroxypropyl methylcellulose acetate succinate and hydroxypropyl methylcellulose phthalate.

S. Baertschi, S. Maple, P. Jansen, 1998, Journal of pharmaceutical sciences.

Aqueous acidic degradation of the carbacephalosporin loracarbef.

K. W. Taylor, M. W. Collins, S. Baertschi, 1993, Journal of pharmaceutical sciences.

Formation of fluorescent pyrazine derivatives via a novel degradation pathway of the carbacephalosporin loracarbef.

M. W. Collins, S. Baertschi, L. A. Spangle, 1995, Journal of Pharmaceutical and Biomedical Analysis.

Isolation and structure elucidation of the major degradation products of cefaclor in the solid state.

M. W. Collins, S. Baertschi, L. A. Spangle, 1997, Journal of pharmaceutical sciences.

Multidimensional evaluation of impurity profiles for generic cephalexin and cefaclor antibiotics

R. Riggin, S. Baertschi, B. Olsen, 1993 .

Pharmaceutical Stress Testing : Predicting Drug Degradation, Second Edition

Karen M. Alsante, Steven W. Baertschi, Robert A. Reed, 2016 .

Comparison of rates of enzymatic oxidation of aflatoxin B1, aflatoxin G1, and sterigmatocystin and activities of the epoxides in forming guanyl-N7 adducts and inducing different genetic responses.

T. Shimada, F. Guengerich, K. Raney, 1989, Chemical research in toxicology.

Implications of In-Use Photostability: Proposed Guidance for Photostability Testing and Labeling to Support the Administration of Photosensitive Pharmaceutical Products, Part 3. Oral Drug Products.

Steven W Baertschi, Robert A Reed, D. Clapham, 2016, Journal of pharmaceutical sciences.

Artifactual degradation of secondary amine‐containing drugs during accelerated stability testing when saturated sodium nitrite solutions are used for humidity control

S. Baertschi, Todd Zelesky, G. Sluggett, 2018, Journal of pharmaceutical and biomedical analysis.

Karen M. Alsante, Margaret S. Landis, G. Stephenson, 2014, AAPS PharmSciTech.

Forced Degradation and Its Relation to Real Time Drug Product Stability

S. Baertschi, 2010 .

Aflatoxin B1Epoxide, the Ultimate Carcinogenic form of Aflatoxin B1: Synthesis and Reaction with Dna

K. Raney, T. Harris, M. Stone, 1989 .

The Degradation Chemistry of Prasugrel Hydrochloride: Part 1-Drug Substance.

K. W. Taylor, S. Baertschi, A. Kaerner, 2019, Journal of pharmaceutical sciences.

Prediction of Drug Degradation Pathways leading to Structural Alerts for Potential Genotoxic Impurities

C. Riley, S. Baertschi, J. Bercu, 2010 .

Stress Testing: A Predictive Tool

Karen M. Alsante, S. Baertschi, P. Jansen, 2016 .

In silico prediction of pharmaceutical degradation pathways: a benchmarking study.

Karen M. Alsante, Steven W Baertschi, Mark H Kleinman, 2014, Molecular pharmaceutics.

The assessment of impurities for genotoxic potential and subsequent control in drug substance and drug product.

Linda K Dow, Marvin M Hansen, Brian W Pack, 2013, Journal of pharmaceutical sciences.

Comprar Pharmaceutical stress testing. Predicting drug degradation | S. Baertschi | 9781439801796 | Informa Healthcare

Karen M. Alsante, R. Reed, S. Baertschi, 2011 .

2-Nitrobenzaldehyde: a convenient UV-A and UV-B chemical actinometer for drug photostability testing.

J. M. Allen, S. Baertschi, S. K. Allen, 2000, Journal of pharmaceutical and biomedical analysis.

The degradation of the antitumor agent gemcitabine hydrochloride in an acidic aqueous solution at pH 3.2 and identification of degradation products.

S. Baertschi, S. Maple, M. Akers, 2000, Journal of pharmaceutical sciences.

Influence of Peroxide Impurities in Povidone and Crospovidone on the Stability of Raloxifene Hydrochloride in Tablets: Identification and Control of an Oxidative Degradation Product

P. Tsang, S. Baertschi, E C Rickard, 2000, Pharmaceutical development and technology.

Isolation, identification, and synthesis of two oxidative degradation products of olanzapine (LY170053) in solid oral formulations.

H. Brunner, S. Baertschi, S. Maple, 2008, Journal of pharmaceutical sciences.

Preparation of the 8,9‐Epoxide of the Mycotoxin Aflatoxin B1: The Ultimate Carcinogenic Species.

K. Raney, T. Harris, M. Stone, 1989 .

Formation of copper(I) from trace levels of copper(II) as an artifactual impurity in the HPLC analysis of olanzapine.

N. Toltl, S. Baertschi, B. Olsen, 2016, Journal of Pharmaceutical and Biomedical Analysis.

Artifactual formylation of the secondary amine of duloxetine hydrochloride by acetonitrile in the presence of titanium dioxide: implications for HPLC method development.

S. Baertschi, B. Winger, M. Skibic, 2010, Journal of pharmaceutical and biomedical analysis.

| Pharmaceutical Stress Testing | Taylor & Francis Group

Karen M. Alsante, R. Reed, S. Baertschi, 2016 .

Karen M. Alsante, Andreas M. Abend, Margaret S. Landis, 2014, AAPS PharmSciTech.

On-column nitrosation of amines observed in liquid chromatography impurity separations employing ammonium hydroxide and acetonitrile as mobile phase.

T. Harris, C. Hadden, S. Baertschi, 2013, Journal of chromatography. A.